510(k) · Cleared

Recalled · 2010

Nucleotome Probe Set, Model 21200

K040919510(k) TraditionalCleared Jun 1, 200454-day reviewClass II21 CFR 888.1100Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jun 1, 2004 as substantially equivalent to K032473 (Stryker Instruments, 2003) and 9 other predicates after a 54-day review. Its family tree reaches back 3 generations to 1992. 17 later devices descend from it. It has been recalled once.

Decided: Jun 1, 2004
Review: 54 days
Class: Class II
Product code: HRX
Recalls: 1
Predicates: 10

Its longest line of descent runs back 3 generations to K922881 (1992). 18 ancestors in all, the oldest K844131 (1984). 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
2 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
1 generation backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
This deviceK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004
Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
Descendant · 3 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
Descendant · 4 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
Descendant · 3 generations on · 5 of its ownK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2006high 4 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 17 · See all

K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · cites it directly14descendants
K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 2 generations on13descendants
K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 3 generations on7descendants
K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 4 generations on6descendants
K212636CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K922881	Clarus Models 1100, 1101, 1102, 1103 Laser Disc	Clarus Medical Systems, Inc.	1992	1
−2	K022610	Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser…	Clarus Medical, LLC	2002	—
−1	K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy…	Clarus Medical, LLC	2004	1
0 (this device)	K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	—
+1	K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	—
+2	K093062	Vertos Medical Mild Device Kit	X-Sten Corp.	2010	—
+3	K180876	DTRAX Spinal System	Providence Medical Technology, Inc.	2018	—
+4	K190201	CORUS Spinal System	Providence Medical Technology, Inc.	2019	—
+3	K212636	CORUS Spinal System-X	Providence Medical Technology, Inc.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1990	1	0
1991	2	0
1993	1	0
1994	1	0
1995	1	0
1997	1	0
1998	1	0
1999	1	0
2001	3	0
2002	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	2	0
2010	1	0
2012	1	0
2018	1	0
2019	1	0
2021	1	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K040919, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (10)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K032473	Dekompressor Percutaneous Discectomy Probe Summary page 1 …ion Name: Arthroscope and Accessories; 888.1100 Predicate Devices: 510(k) Description Manufacturer K032473 Stryker DekompressorTM Precutaneous Discectomy Probe Stryker Instruments K844131 Nucleotome…	Stryker Instruments	2003	3
*	K844131	Nucleotome Summary page 1 …ription Manufacturer K032473 Stryker DekompressorTM Precutaneous Discectomy Probe Stryker Instruments K844131 Nucleotome Clarus Medical, LLC* K902778 Nucleotome I1 Tissue Aspirat…	Medical Instrument Development Laboratories, Inc.	1984	—
*	K902778	Surgical Dynamics Nucleotome II Tissue Aspir/Cuter Summary page 1 …ompressorTM Precutaneous Discectomy Probe Stryker Instruments K844131 Nucleotome Clarus Medical, LLC* K902778 Nucleotome I1 Tissue Aspiration/Cutter Clarus Medical, LLC* K913145 Nucleotome Tissue Aspirator/…	Surgical Dynamics, Inc.	1990	—
*	K913145	Nucleotome Tissue Aspirator/Cutter Summary page 1 …Clarus Medical, LLC* K902778 Nucleotome I1 Tissue Aspiration/Cutter Clarus Medical, LLC* K913145 Nucleotome Tissue Aspirator/Cutter Clarus Medical, LLC* K914282 Nucleotome(r) II (version2)…	Surgical Dynamics, Inc.	1991	—
*	K914282	Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter Summary page 1 …1 Tissue Aspiration/Cutter Clarus Medical, LLC* K913145 Nucleotome Tissue Aspirator/Cutter Clarus Medical, LLC* K914282 Nucleotome(r) II (version2) Tissue Aspiration/Cutter Clarus Medical, LLC* K923525 Nucleotome 3.5 mm Automated…	Surgical Dynamics, Inc.	1991	—
*	K923525	Nucleotome 3.5 MM Automated Percutaneous Lumbar Summary page 1 …issue Aspirator/Cutter Clarus Medical, LLC* K914282 Nucleotome(r) II (version2) Tissue Aspiration/Cutter Clarus Medical, LLC* K923525 Nucleotome 3.5 mm Automated Percutaneous Lumbar Clarus Medical, LLC* K931109 Nucleotome E Kit…	Surgical Dynamics, Inc.	1993	—
*	K931109	Nucleotome E Kit Summary page 1 …) II (version2) Tissue Aspiration/Cutter Clarus Medical, LLC* K923525 Nucleotome 3.5 mm Automated Percutaneous Lumbar Clarus Medical, LLC* K931109 Nucleotome E Kit Clams Medical, LLC* K942987 Nucleotome L Kit…	Surgical Dynamics, Inc.	1994	—
*	K942987	Nucleotome L Kit Summary page 1 …3.5 mm Automated Percutaneous Lumbar Clarus Medical, LLC* K931109 Nucleotome E Kit Clams Medical, LLC* K942987 Nucleotome L Kit Clarus Medical, LLC* K011454 Model 2180 Spinescope Endosc…	Surgical Dynamics, Inc.	1995	—
*	K011454	Spine Scope, Model 2180 Summary page 1 …E Kit Clams Medical, LLC* K942987 Nucleotome L Kit Clarus Medical, LLC* K011454 Model 2180 Spinescope Endoscope Clarus Medical, LLC K040424 Model 1100 Laser Endoscopic D…	Clarus Medical, LLC	2001	—
*	K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model… Cleared while this submission was under review Summary page 1 …L Kit Clarus Medical, LLC* K011454 Model 2180 Spinescope Endoscope Clarus Medical, LLC K040424 Model 1100 Laser Endoscopic Decompression Kit (Pending) Clarus Medical, LLC…	Clarus Medical, LLC	2004	1

Also cleared against K032473: 4 other devices →

What descends from it? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	14
K092877	Indiscal Aspiration Device and Accessories	Baylis Medical Co., Inc.	2009	0
K090303	Xtend-ST Nucleus Removal System, Model 9004	Corespine Technologies, LLC	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 5, 2010	Not classified	Z-1795-2010	Other	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
3 of the 18 ancestors have a recall of any class.
Of its descendants, K062038 (X-Sten Corp., 2006) has gone furthest, with 14 descendants of its own.
4 other devices also cite its predicate K032473.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Clarus Model 21200 Nucleotome Probe Set is indicated for use in aspiration of disc

material during percutaneous discectomies in the lumbar, thoracic, and cervical regions

of the spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040919 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040919: Nucleotome Probe Set, Model 21200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040919

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026